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This study is designed to evaluate the efficacy and the safety of YH23537 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.
at screening visit, at least existing 18 teeth,Mild/moderate/severe periodontitis patients diagnosed with chronic periodontitis according to the CDC / AAP (Center for Disease Control / American Academy for Periodontology) periodontitis classification (2012).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH23537 1000mg/day | Experimental | YH23537 500mg 1 tab, placebo 500mg 2tab twice a day (before morning,evening meal) during 12 weeks |
|
| YH23537 2000mg/day | Experimental | YH23537 500mg 2tab, placebo 500mg 1tab twice day (before morning,evening meal) during 12 weeks |
|
| YH23537 3000mg/day | Experimental | YH23537 500mg 3tab a day twice day (before morning,evening meal) during 12 weeks |
|
| YH23537 3000mg/day loading 1000mg/day | Experimental | YH23537 500mg 3tab twice a day (before morning,evening meal) during 4weeks and YH23537 500mg tab twice a day (before morning,evening meal) during 8weeks |
|
| Placebo | Placebo Comparator | YH23537 500mg placebo 3tab twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH23537 1000mg/day | Drug | YH23537 500mg 2 tab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in probing pocket depth (PD) | baseline, 4weeks, 8week, 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical attachment level (CAL) | baseline, 4weeks, 8week, 12weeks | |
| Change in Bleeding on probing(BOP) | baseline, 4weeks, 8week, 12weeks | |
| Change in Gingival recession(GR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Incheol Rhyu, Ph.D. | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incheol Rhyu | Seoul | South Korea |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| YH23537 2000mg/day | Drug | YH23537 500mg 4 tab |
|
| YH23537 3000mg/day | Drug | YH23537 500mg 6 tab |
|
| placebo | Drug | YH23537 500mg tab placebo |
|
| baseline, 4weeks, 8week, 12weeks |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |